- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01227473
We Can Prevent Diabetes: A Behavioral Intervention to Reduce Diabetes Risk in African Americans
A Mindfulness-based Intervention to Reduce Diabetes Risk in Pre-diabetic African Americans
Přehled studie
Postavení
Podmínky
Detailní popis
Pre-diabetes, characterized by glucose levels that are above normal but below the diagnostic criteria for diabetes, is an increasingly common condition affecting approximately 54 million U.S. adults. African Americans are disproportionately affected by pre-diabetes and experience high rates of diabetes-associated morbidity and mortality including damage to the circulatory system, kidneys, and nervous system. Patients with pre-diabetes who increase their physical activity and improve their diets have reduced risk of developing diabetes. Psychological distress negatively influences the course of the disease by increasing deleterious health behaviors; preventing scheduling and maintenance of positive behavior change; and stimulating HPA-axis activation and dysregulation, which may have a direct impact on insulin resistance and glucose metabolism. African Americans may have increased exposure to stress and increased vulnerability to adverse stress-related health outcomes like diabetes, because of their unique history, sociocultural experiences, and societal position in the U.S. Helping individuals to reduce stress and to increase healthy coping strategies may enhance conventional diabetes prevention efforts, especially among African Americans.
Mindfulness-based stress reduction (MBSR), a mind-body practice with a wide range of health benefits, has been shown to result in statistically significant reductions in psychological stress and anxiety in randomized, controlled studies. Mindfulness training is cost-effective in comparison with other small-group or individualized programs, and can be taught safely and effectively by well-trained instructors. There is little research, and no randomized, controlled trials of MBSR as a treatment for individuals with pre-diabetes. There is also little research on the acceptability of MBSR program to a prediabetic subgroup of African Americans, or on the acceptability of an MBSR program for a general population of African Americans.
Overall goals of this exploratory pilot study are to study the potential efficacy of a diabetes prevention education program that includes training in mindfulness-based stress reduction for pre-diabetic African Americans. Specific Aims are 1) to determine the feasibility of developing a clinical trial to compare the effectiveness of a mindfulness-based diabetes prevention program (treatment group) with a conventional diabetes prevention program (control group) in improving glucose metabolism in pre-diabetic African American adults; 2) to identify relevant physiological and psychological secondary outcomes associated with a mindfulness-based, educational self-care program in African-Americans with pre-diabetes; 3) to assess the acceptability and cultural relevance of MBSR for pre-diabetic African Americans via a post-intervention qualitative study, to include interviews of participants, dropouts, and instructors; and 4) to identify, and find solutions for, problems in conducting a well-powered clinical trial to assess the efficacy of a mindfulness-based diabetes prevention program in improving glucose metabolism in pre-diabetic African-Americans.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
- Fáze 1
Kontakty a umístění
Studijní místa
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North Carolina
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Chapel Hill, North Carolina, Spojené státy, 27599
- University of North Carolina at Chapel Hill
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- African-American
- 25-65 years of age
- meeting the ADA criteria for pre-diabetes (either by fasting plasma glucose (FPG) of 100-125 mg/dl or glucose of 140-199 mg/dl at 2 hours in an oral glucose tolerance test (OGTT))or a HbA1c of 5.7-6.4%
- experiencing some degree of stress
- willing to attend 1 1/2 hour group meetings once weekly for 8 weeks, followed by monthly booster sessions for six months, and to complete assessment instruments.
Exclusion Criteria:
- diabetes diagnosed by a physician
- past or current use of hypoglycemic medication (except gestational diabetes)
- disease associated with disordered glucose metabolism
- use of medications associated with impaired glucose metabolism
- active treatment for or history of a major medical illness
- previous training in meditation or mindful yoga, tai chi, qigong
- pregnant or planning a pregnancy
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: mindfulness prediabetes education group
The mindfulness-based diabetes prevention education group meets for 2 ½ hours per week for eight weeks, with one 4-hour retreat between the 6th and 7th weeks, and monthly booster sessions for 6 months.
During the 8-week interventions, the group receives a 30-minute health behavior presentation (based on the landmark Diabetes Prevention Program).
In the mindfulness-based diabetes prevention group, the instruction will be enhanced with instruction in mindfulness.
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The mindfulness-based diabetes prevention group meets for 2 ½ hours per week for eight weeks, with one 4-hour retreat between the 6th and 7th weeks, and monthly booster sessions for 6 months.
During the 8-week interventions, this group receives a 30-minute health behavior presentation (based on the landmark Diabetes Prevention Program).
In the mindfulness-based diabetes prevention group, the instruction will be enhanced with a modified mindfulness meditation training designed to support the behavioral-change programming.
Ostatní jména:
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Aktivní komparátor: conventional prediabetes education group
The conventional diabetes prevention education group meets for 2 ½ hours per week for eight weeks, with one 4-hour retreat between the 6th and 7th weeks, and monthly booster sessions for 6 months.
During the 8-week interventions, the group receives a 30-minute health behavior presentation (based on the landmark Diabetes Prevention Program).
In the conventional diabetes prevention group, the instruction will be enhanced with group exercises and discussions.
|
The conventional diabetes prevention education group meets for 2 ½ hours per week for eight weeks, with one 4-hour retreat between the 6th and 7th weeks, and monthly booster sessions for 6 months.
During the 8-week interventions, the group receives a 30-minute health behavior presentation (based on the landmark Diabetes Prevention Program).
In the conventional diabetes prevention group, the instruction will be enhanced with group exercises and discussions.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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insulin resistance, as measured by the homeostatic model assessment-insulin resistance (HOMA-IR)
Časové okno: Fasting samples will be collected 3 weeks, on average, before the intervention and at 3 months post intervention.
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The homeostatic model assessment-insulin resistance (HOMA-IR) is a calculated measure based on the FPG and fasting insulin levels.
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Fasting samples will be collected 3 weeks, on average, before the intervention and at 3 months post intervention.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Salivary cortisol
Časové okno: Salivary cortisol will be measured before the intervention and at 2 weeks, 3 months, and 6 months post intervention
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Salivary cortisol will be measured before the intervention and at 2 weeks, 3 months, and 6 months post intervention
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Insulin resistance as measured by the HOMA-IR
Časové okno: 2 weeks and 6 months post-intervention
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The HOMA-IR is calculated from the fasting insulin and fasting glucose.
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2 weeks and 6 months post-intervention
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Susan Gaylord, PhD, University of North Carolina, Chapel Hill
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 09-0563
- 1R21AT004276-01A (Jiný identifikátor: NIH NCCAM)
- 1R21AT004276-01 (Grant/smlouva NIH USA)
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